Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training (RAGT) in Children With Cerebral Palsy

Cerebral palsy (CP) is a common cause of gait impairment in children, leading to limitations in mobility and daily activities. Although conventional physical therapy is widely used, it has limitations in delivering consistent and intensive training. Robot-assisted gait training (RAGT) has emerged as a promising approach to provide repetitive, high-intensity, and task-specific training, with potential benefits in gait function and motor performance. The Bambini Kids exoskeleton is a pediatric robotic device designed to assist lower-limb movements, including hip, knee, and ankle joints, to facilitate more natural gait patterns. This study aims to evaluate the safety and clinical performance of Bambini Kids in children with cerebral palsy and to generate clinical evidence to support its use in real-world rehabilitation settings.

Cerebral palsy (CP) is one of the most common causes of gait impairment in children, and it's a non-progressive neurodevelopmental disorder that results in permanent impairments in motor function and postural control. The prevalence of cerebral palsy in Korea has been reported to be approximately 2.6 per 1,000 individuals. Patients with CP experience limitations in gait and activities of daily living due to muscle spasticity, muscle weakness, and impairments in balance and coordination, which consequently lead to reduced independence and decreased quality of life. Physical activity is essential for promoting overall health in children with cerebral palsy, and has been shown to improve stability, balance, overall motor function, and aerobic capacity, while reducing the risk of depression and enhancing key functional domains such as social participation and quality of life. To achieve these benefits, conventional physical therapy approaches, including partial body weight-supported gait training, task-oriented training, and treadmill-based training, have been widely used; however, these approaches are associated with substantial physical burden on therapists and limitations in consistently providing repetitive and high-intensity training. To address these limitations, robot-assisted gait training (RAGT) is getting attention in the field of rehabilitation. RAGT enables the consistent delivery of high-intensity and high-frequency repetitive training in accordance with physiological gait patterns and allows automatic recording of training parameters for objective analysis and comparison. In addition, some wearable exoskeleton can be applied in non-clinical settings, thereby expanding their potential use beyond hospital environments. The therapeutic effects of robot-assisted gait training (RAGT) have been demonstrated in adult patients with spinal cord injury (SCI) and stroke through multiple randomized controlled trials and systematic reviews, showing positive impacts on gait ability, muscle strength, balance, and recovery of activities of daily living. Studies in children with cerebral palsy have also reported that RAGT has a beneficial effect on activity-related outcomes such as standing ability, gait speed, and walking distance. Early application of rehabilitation in children during developmental stages is of particular clinical importance, as it may promote neuroplasticity during periods when gait patterns and motor function remain modifiable, thereby potentially preventing long-term progression of disability. In a recent multicenter clinical study, significant improvements in gross motor function, balance control, and gait patterns were observed after 6 weeks of robot-assisted gait training, and these effects were maintained at follow-up. Borggraefe et al. reported that patients with milder impairment (GMFCS Levels I-II) showed significantly greater improvements in Gross Motor Function Measure(GMFM-88) dimensions D and E compared to those with trial.show_full_description

Inclusion Criteria: Subjects eligible for participation in this clinical investigation shall meet all of the following criteria. * Patient diagnosed with Cerebral Palsy * Age from 2 to 10 years old * Classified as Levels II to IV according to GMFCS * Manual Muscle Testing, MMT score of 0 to 4 * Modified Ashworth Scale, MAS score of 3 and under * Subjects with sufficient cognitive function to comply with study procedures * Subjects with adequate upper limb function required for device use and study procedures * Subjects who meet the physical requirements for use of the medical device as defined by the manufacturer Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for participation in the clinical investigation. * Subjects who do not meet the criteria of age, height, weight, body dimensions, or joint range of motion * Subjects with skin lesions, pressure sores, infections, or other conditions at area where device touches and makes difficult to use device * Classified as Levels V according to GMFCS * Subjects with severe spasticity (MAS \> 3), or those at risk of significant worsening of spasticity after training. * Subjects unable to maintain an upright standing position for at least 15 minutes (e.g., due to autonomic dysreflexia or orthostatic hypotension) * Subjects with significant cardiovascular disease or a history of myocardial infarction within the past 6 months * Subjects with medical conditions that are contraindications for use of the medical device as defined by the manufacturer. * Subjects for whom weight-bearing, standing, or gait training is medically contraindicated (e.g., fractures, severe osteoporosis, severe joint deformity, or joint instability) * Subjects who have received treatments affecting muscle tone within the past 4 months, such as botulinum toxin injections or baclofen pump implantation * Subjects who experience adverse events or undesirable side effects during the clinical investigation that make continued participation difficult * Subjects whom the investigator judges to be unsuitable for participation or continuation in the clinical investigation.